1. Name Of The Medicinal Product
Pulvinal® Salbutamol 200 micrograms/metered dose inhalation powder.
2. Qualitative And Quantitative Composition
Each actuation provides salbutamol 200 micrograms (metered dose) or 188 micrograms as emitted dose.
For excipients, see 6.1.
3. Pharmaceutical Form
Inhalation powder administered from a multidose powder inhaler.
4. Clinical Particulars
4.1 Therapeutic Indications
Pulvinal Salbutamol is indicated for the relief of symptoms of asthma, bronchospasm and/or reversible airways obstruction and for the prevention of exercise-and allergen-induced asthma.
Pulvinal Salbutamol is particularly suitable for the relief of symptoms in mild, moderate and severe asthma.
The use of an inhaled β2-agonist must not delay the introduction of regular inhaled corticosteroid therapy.
4.2 Posology And Method Of Administration
Pulvinal Salbutamol is for inhalation use only.
Each inhalation of Pulvinal Salbutamol provides 200 micrograms of salbutamol.
Adults:
For the relief of asthma symptoms, including acute bronchospasm, and for managing intermittent episodes of asthma, one inhalation should be administered.
For prevention of exercise-or allergen-induced asthmatic symptoms, one inhalation should be taken 10-15 minutes before challenge.
There is no need to adjust the dosage in elderly patients.
Children aged above 6 years:
One inhalation for the relief of asthma symptoms, including acute bronchospasm, for the management of episodic asthma, or 10-15 minutes before allergen exposure or exercise.
Use of Pulvinal Salbutamol should not exceed four inhalations (i.e. 800 micrograms) in 24 hours.
The bronchodilator effect of salbutamol lasts for a minimum of 4 hours, except in those patients whose asthma is worsening. Patients should be warned not to increase the dosage and to seek medical advice in case of worsening of their asthma symptoms. Frequent supplementary use of salbutamol or a sudden increase in dose is likely to indicate poorly controlled or deteriorating asthma.
Instructions for use –
Do not remove the cap protecting the inhaler until the moment of use.
Unscrew the protective cap and before twisting the inhaler, hold it upright and tap it gently against a hard surface to level the powder in the chamber.
Holding the inhaler upright press the blue button on the mouth piece and rotate the inhaler body anti-clockwise until the red mark on the body shows through the hole in the mouthpiece (dose-loading position).
While still holding the inhaler upright, rotate the inhaler body clockwise until the green mark on the body shows through the hole in the mouthpiece (dose-delivery position).
Breathe out deeply. While still holding the inhaler upright put the mouthpiece between your lips and breathe in through your mouth. Hold your breath for a few seconds.
To obtain full therapeutic benefit, it is essential that the patient follows the instructions for use (see patient information leaflet) carefully.
4.3 Contraindications
Pulvinal Salbutamol is contra-indicated in patients with a history of hypersensitivity to either salbutamol or lactose (see Section 4.4. below).
Inhaled salbutamol preparations are not appropriate in the management of premature labour and in threatened abortion.
4.4 Special Warnings And Precautions For Use
The dosage and frequency of administration of inhaled salbutamol should only be increased on medical advice. If a previously effective dose of Pulvinal Salbutamol fails to provide relief lasting for a minimum of three hours, or in the event of increased use of the product, the patient should be advised to seek medical advice, as this may be indicative of deteriorating asthma. In situations where asthma control may appear to be deteriorating, patients should be re-assessed and consideration given to increasing anti-inflammatory therapy.
Patients with severe or unstable asthma are at risk of acute severe episodes and even death and should not be treated only or mainly with bronchodilators. Such patients may require regular medical assessment, including lung function testing, and may require treatment with the maximum recommended dose of inhaled corticosteroids and/or with oral corticosteroids.
Severe exacerbations of asthma must be treated in the usual way.
Salbutamol should be administered cautiously in patients affected by thyrotoxicosis. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Salbutamol should not be administered together with non-selective β-blockers. Concomitant administration of xanthine derivatives, diuretics or steroids may lead to severe hypokalaemia; serum potassium levels should be monitored carefully in such cases.
4.6 Pregnancy And Lactation
As with the majority of drugs, salbutamol should not be administered during the first three months of pregnancy. Further use of the product during pregnancy should be restricted to those situations where the expected therapeutic benefit to the mother outweighs any possible risk to the foetus.
In animal studies, administration of salbutamol at very high doses resulted in some harmful effects on the foetus.
Salbutamol is likely to be secreted in breast milk and its effect on breast-fed neonates is not known. Hence, the product should be used in lactation only where the expected benefit to the mother outweighs any potential risk to the neonate.
4.7 Effects On Ability To Drive And Use Machines
None
4.8 Undesirable Effects
Tachycardia, with or without peripheral vasodilatation, may occur rarely.
Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) have been reported in association with β2–agonists, usually in susceptible patients.
As with all beta-adrenergic agonists administration of inhaled salbutamol may cause dose-related fine tremors of skeletal muscle.
Headaches have occasionally been reported.
There have been rare reports of muscle cramps.
As with any other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator and Pulvinal Salbutamol should be discontinued straightaway. The patient should be assessed and, if necessary, alternative therapy instituted.
Potentially serious hypokalaemia, which can be potentiated by hypoxia and therefore be worse in acute severe asthma, may result from β2-agonist therapy. Therefore particular caution is advised in acute severe asthma.
As with other β-adrenergic drugs, also with salbutamol there have been rare reports of hyperactivity in children.
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely.
Patients sensitive to the inhalation of a dry powder may occasionally develop throat irritation and cough; this can be minimised by rinsing the mouth after inhalation.
4.9 Overdose
Administration of inhaled salbutamol exceeding the recommended dosage does not generally produce harmful effects; should accidental overdose occur, a cardioselective β-blocking agent should be used, though β-blockers are to be administered with caution in patients with a history of bronchospasm.
As salbutamol overdose may cause hypokalaemia, serum potassium should be monitored.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Salbutamol is a selective β2-stimulant providing marked bronchodilatation, which lasts 4-6 hours. This activity makes this drug particularly suitable for the management of asthma and related diseases characterised by a bronchospastic component.
5.2 Pharmacokinetic Properties
Only 10% of inhaled salbutamol is deposited in the airways and the remainder is retained in the delivery system or is swallowed. The swallowed portion is absorbed through the gut wall, and passed via the liver to the systemic circulation. Salbutamol is readily absorbed from the gastro-intestinal tract and undergoes an extensive presystemic metabolism. The major metabolite is the sulphate conjugate, which is inactive. Up to 80% of the dose administered is recovered in the 24-hour urine, either unchanged or in the form of inactive metabolites. Salbutamol does not appear to be metabolised in the lung where it exerts a local action. In general, inhaled doses are lower than oral doses and blood levels are correspondingly smaller and associated with less severe non-respiratory side effects.
5.3 Preclinical Safety Data
Subacute and chronic toxicity: (inhalation, rat, 6 weeks) no evidence of toxicity or significant histological changes for doses up to 3.3mg/kg over a time of 3 hours daily; (inhalation, rat) doses up to 0.6mg/kg for 6 months did not produce toxic effects; (inhalation, dog, 12 weeks) no signs of toxicity or histological changes were observed following daily administration of 0.15 mg/kg; (oral, rat, 17-18 weeks and 18 months) dose-related (1-50 mg/kg) increase in the incidence of Harderian gland hypertrophy and in the amount of colloid material in the Rathke's pouch area of the pituitary gland. Both glands are involved in the production of melanophore-stimulating hormone (MSH) which has been associated with stimulation of the β-adrenergic receptors.
Reproduction toxicity: (rat) reproduction studies at 0.5
Mutagenicity and carcinogenicity: no mutagenic potential was found in “in vitro” tests and no carcinogenic effects were seen in mice; in rats at very high doses an increase of benign mesovarian leiomyomas was found, as an expression of the excessive β-blocker pharmacological activity.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose monohydrate
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
24 months
6.4 Special Precautions For Storage
Do not store above 30°C. Keep the container tightly closed.
6.5 Nature And Contents Of Container
Multidose dry powder inhaler (Pulvinal consisting of a pale blue mouthpiece, a transparent body-reservoir, a deep blue base containing a desiccant and a blue protective cap.
Pulvinal Salbutamol provides 100 metered doses.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Chiesi Limited
Cheadle Royal Business Park
Highfield
Cheadle
SK8 3GY
United Kingdom
8. Marketing Authorisation Number(S)
PL 08829/0152
9. Date Of First Authorisation/Renewal Of The Authorisation
1st March 2004
10. Date Of Revision Of The Text
22/12/2008
11. LEGAL CATEGORY
POM
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